MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	CAGEN1ZD
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during microwave ablation of a liver tumor, an error message "fatal error" showed in the unit.It was the error the hand and the box with an arrow coming out and it would not allow to reset it.The procedure was aborted and re-scheduled on the next day with new generator.There was no patient injury.

• Brand Name: EMPRINT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 11463705
• Report Number: 3004962788-2021-00020
• Device Sequence Number: 11670546
• Product Code: NEY
• UDI-Device Identifier: 10884521552579
• UDI-Public: 10884521552579
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAGEN1ZD
• Device Catalogue Number: CAGEN1ZD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 127